By Bryant Godfrey and Jashaswi Ghosh (July 30, 2025 – Originally on Law360)

The pharmaceutical sectors of the U.S. and India share more than just a connection; they represent a strategic partnership pivotal to the future of global healthcare.

Each country significantly influences the pharmaceutical landscape, with the U.S. leading advancements in life sciences innovation, and India serving as a crucial global manufacturing center.

As regulatory frameworks and healthcare objectives evolve within both nations, the importance of this collaboration is amplified. This article dives into the opportunities, the challenges and the strategies companies should consider to navigate this dynamic space.

A Partnership Built on Strength

India has long been a powerhouse in supplying affordable, high- quality generic medicines to the U.S. market.[1] Its skilled workforce, efficient manufacturing setups and expanding biopharma expertise make it a valuable partner for American companies. In return, Indian firms get access to the largest pharmaceutical market globally, creating mutual advantages in production, research and technology exchange.

Joint ventures between U.S. and Indian firms are driving progress in key areas like biosimilars, complex generics and vaccines[2]. Moreover, India’s vast patient population offers strategic benefits for clinical trials, provided these trials meet stringent FDA and international quality standards. This close collaboration fosters innovation and enhances competitiveness on both sides.

Navigating Regulatory Challenges

Recent policy and regulatory changes in both countries will have an impact on how pharmaceutical companies operate and navigate in this space. The U.S. is increasingly focused on reducing dependency on imported medicines, emphasizing domestic manufacturing and supply chain security.

Additionally, the FDA is ramping up inspections and enforcing strict standards, especially regarding manufacturing quality and data integrity for offshore facilities.

For Indian companies targeting the U.S. market, ensuring rigorous quality assurance and being ready for unannounced inspections is crucial. Clinical trials conducted in India must also strictly adhere to global ethical and safety standards, making robust oversight and documentation essential.

For example, FDA guidelines require foreign clinical trials supporting U.S. drug applications to adhere to good clinical practice guidelines. Similarly, manufacturing sites must follow current good manufacturing practice standards, and firms should be ready for unannounced inspections of their Indian facilities to verify compliance and data integrity.[3]

Within the first few months, the current U.S. administration has passed several executive orders aimed at lowering prescription drug prices and reinforce the “America First” principles within pharmaceutical production.

Albeit indirectly, these executive orders will significantly influence the international life sciences industry, and this especially has a significant impact on India and the Indian pharmaceutical sector, given its prominent position in the global generic medicine supply chain.

These policy adjustments present both new opportunities and heightened regulatory scrutiny for Indian manufacturers, prompting them to proactively prepare for potential changes.

Three recent executive orders from the current U.S. administration have set clear priorities aimed at lowering prescription drug prices and revitalizing domestic pharmaceutical manufacturing capabilities.

One key directive, issued on May 5,[4] specifically tasks agencies such as the U.S. Department of Health and Human Services, U.S. Food and Drug Administration and U.S. Environmental Protection Agency with streamlining regulatory processes, reducing redundancies and speeding up the approvals needed to establish domestic pharmaceutical production facilities.

This initiative notably emphasizes increased scrutiny and oversight of foreign manufacturing operations by mandating that the FDA publish foreign facility inspection outcomes and strengthen its risk-based inspection protocols, funded in part by higher fees levied on international producers.

India boasts a robust pharmaceutical infrastructure, comprising over 10,000 manufacturing units, more than 3,000 pharmaceutical companies, and 650 facilities that meet U.S. FDA standards, the highest number of such compliant plants outside the U.S.[5]

Given India’s prominent role as host to the highest number of FDA-registered overseas facilities supplying the U.S. market, these heightened oversight measures carry substantial implications for Indian manufacturers.

Another significant executive order[6] requires the FDA, by October 2025, to put forth recommendations aimed at accelerating the regulatory review and approval timelines for generic medicines, biosimilars, combination drugs and second-in-class branded medications, alongside initiatives to simplify the transition of certain prescription medications to over- the-counter status.

Considering India’s established leadership in complex generics, Indian pharmaceutical firms stand to benefit considerably if they can leverage these streamlined approval processes.

Finally, the introduction of a most-favored-nation pricing policy[7] aligns U.S. pharmaceutical prices more closely with those observed in other developed nations. If substantial progress in pricing reductions is not achieved, federal agencies are authorized to explore remedies including drug importation, price regulation measures and potentially withdrawing product approvals — although, there likely will be challenges with the latter if the withdrawal does not meet the statutory criteria for that action as outlined in the Federal Food, Drug, and Cosmetic Act.[8]

For Indian manufacturers, this most-favored-nation pricing framework presents dual implications. It may enhance their market opportunities as suppliers of competitively priced drugs, but simultaneously subject them to more rigorous oversight regarding pricing practices and compliance requirements.

Collectively, these executive actions have significant potential to reshape market dynamics, operational models and regulatory compliance obligations across India’s pharmaceutical manufacturing landscape.

Trade and Tariffs: A Complex Landscape

While pharmaceuticals have largely avoided the brunt of recent tariff disputes, ongoing trade tensions remain a concern. Indian manufacturers, especially those reliant on Chinese raw materials, must proactively diversify their supply sources to mitigate risks associated with potential policy changes. Companies must adopt flexible strategies to ensure uninterrupted supply chains.

Indian life sciences and pharmaceutical firms are poised to gain from ongoing trade talks between India and the U.S.[9] A potential bilateral trade agreement would aim for closer regulatory alignment and streamlined drug approval processes, both of which would make it easier and faster for Indian therapies to be released on the U.S. market.

Both nations agreed to bolster collaborative innovation, exemplified by new partnerships between their research agencies to spur joint research and development in emerging health technologies and manufacturing.[10]

Collaborative efforts would also include building resilient shared supply chains, expanding India’s capacity for critical drug ingredients, diversifying sources to strengthen resilience and reduce the risk of medicine shortages in both countries.[11]

Opportunities in the Indian Market for U.S. Companies

India’s healthcare market is rapidly expanding, driven by increased disposable income, rising health awareness and supportive government policies.

Valued at around $370 billion in 2022, the market is projected to reach over $600 billion in 2025, reflecting an impressive growth rate of roughly 22%.[12] The government has signalled its commitment through initiatives like increasing public health spending, targeting 2.5% of GDP in 2025.[13]

Additionally, as the fifth-largest contributor to India’s manufacturing gross value added, the pharmaceutical sector plays a pivotal role in the economy — accounting for around 4% of the country’s total foreign direct investment inflows.[14]

It also maintains a robust trade surplus of $19 billion and underpins the livelihoods of approximately 2.7 million people across direct and indirect employment channels.[15]

U.S. companies entering India might find success by launching branded generics, which still account for over 75% of drug volume and 90% of value in India,[16] focusing on chronic disease treatments, and tapping into growing therapeutic areas like oncology, diabetes and autoimmune conditions.

Chronic diseases are a major concern — noncommunicable ailments now account for over 60% of deaths nationwide, and India already has more than 77 million adults with diabetes

— underscoring the demand for long-term treatments.[17]

Opportunities also abound in consumer health, especially through digital health platforms and e-commerce. For example, India’s digital health sector is poised to surge from about

$2.7 billion in 2022 to roughly 37 billion by 2030, creating vast new channels for reaching consumers.[18]

Although India’s regulatory environment remains intricate, recent policy shifts aimed at simplifying clinical trial approvals and promoting orphan drug development are encouraging signs.[19] India’s growing contract research and manufacturing services sector provides a cost-effective way for U.S. companies to scale research and manufacturing operations.

U.S. Market Strategies for Indian Firms

Indian companies eyeing the U.S. will likely continue focusing on complex generics, biosimilars and specialty drugs. While these areas come with higher regulatory demands, they also offer attractive profit margins.

Companies that invest in advanced research and development, rigorous clinical trial frameworks and strategic IP management will find it easier to compete. Given India’s sophistication and strength in the manufacturing of pharmaceuticals, opportunities exist for Indian drug manufacturers to pursue becoming producers of innovative products as well.

Digital health solutions, including AI-driven diagnostics and real-world evidence platforms, also represent significant opportunities. Collaborating with American biotech firms, contract manufacturers or commercialization partners can streamline market entry and maximize success.

Indian pharma, biotech and medtech companies can capitalize on this landscape with a few key strategies. First, pursuing partnerships with American biotech firms or service providers can accelerate U.S. market entry — experts note that joint ventures, scientific collaborations and tie-ups between Indian and U.S. companies are critical for success.[20]

Aligning early with FDA regulatory requirements and digital health guidelines is essential. The FDA is actively harmonizing internal standards for digital health technologies,[21] so Indian innovators should design their AI and software tools to meet U.S. quality and compliance standards from the outset.

Finally, firms should leverage India’s formidable IT and engineering talent as a competitive advantage. India’s highly skilled tech workforce is recognized as an asset in advanced fields like AI,[22] which means Indian companies can rapidly develop and refine digital health solutions, from AI-driven diagnostics to health data analytics, at a lower cost.

For instance, healthcare organizations have already begun outsourcing their administrative functions, such as virtual assistant services, to countries like India. This trend has been driven by India’s abundant skilled workforce and robust information technology infrastructure, enabling providers to alleviate key operational challenges, most notably physician burnout, by reducing the administrative burden on clinical staff.

By combining U.S. partnerships, regulatory alignment and India’s IT prowess, Indian companies will be well positioned to navigate relevant FDA requirements and deliver cutting-edge digital health offerings for the U.S. market.

Conclusion

The U.S.-India pharmaceutical corridor is no longer simply about cost-saving measures. It’s evolving into a sophisticated partnership influenced by innovation, regulation, geopolitics and patient needs. Companies prepared to embrace quality, compliance and strategic partnerships aren’t just poised to survive — they’re positioned to lead.

Bryant M. Godfrey is a partner and co-chair of the healthcare department and chair of the Food and Drug Administration practice group at Foley Hoag LLP. He previously served as senior lead regulatory counsel in the Center for Drug Evaluation and Research, Office of Medical Policy, Office of Prescription Drug Promotion, at the FDA.

Jashaswi Ghosh is counsel at Holon Law Partners LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of their employer, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

1. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/us- india-medicine-partnership.
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC9865573/.
3. FDA Guidance Documents (fda.gov).
4. https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote- domestic-production-of-critical-medicines/.
5. https://www.bain.com/insights/healing-the-world-a-roadmap-for-making-india-a-global- pharma-exports-hub/.
6. https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by- once-again-putting-americans-first/.
7. https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored- nation-prescription-drug-pricing-to-american-patients/.
8. See 21 S.C. 355(e).
9. Carnegie Endowment, The India-US TRUST Initiative – A resilient Pharma Supply Chain (carnegieendowment.org).
10. The White House, United States – India Joint Leaders’ Statement (whitehouse.gov).
11. The White House, United States – India Joint Leaders’ Statement (whitehouse.gov).
12. Healthcare Market Insignts for India, Informa Markets (www.indiahealth- com).
13. India’s Healthcare Boom: AI-Powered Growth Set to Reshape a $650 Billion Industry by 2025 (www.lexology.com); Five Pillars of Growth in India’s Healtcare Sector (www.buziness-sweden).
14. https://www.bain.com/insights/healing-the-world-a-roadmap-for-making-india-a- global-pharma-exports-hub/.
15. ID
16. NMC puts in abeyance regulation mandating doctors to prescribe generic drugs (pharmabiz.com).
17. World Health Organization, Diabetes in India (www.who.int).
18. Boston Consulting Group, Digital Health Care on the Rise in India (bcg.com).
19. https://globalforum.diaglobal.org/issue/december-2024/the-evolving-regulatory- framework-in-india-impact-on-the-pharmaceutical-industry/.
20. Indo-US Pharma Alliance, Time to Up the Game (www.ipa-org).